Monolithic matrix transdermal delivery system for administering molsidomine

Abstract

This invention provides monolithic matrix formulations for transdermal administration of molsidomine. The device includes a copolymer of 2-ethylhexyl acrylate, 2-hydroxyethylmethacrylate, and methacrylic acid. The invention also provides transdermal devices having a monolithic matrix made using such a formulation in combination with an active ingredient and a vehicle or vehicle formulation.

What is claimed is: 
     
       1. A laminated device for transdermal administration of molsidomine comprising a backing layer and a matrix layer, the matrix layer comprising: molsidomine; and   an adhesive copolymer composition comprising between 60 and 98 wt % of 2-ethylhexyl acrylate, between 0.1 and 25 wt % of 2-hydroxyethyl methacrylate, and between 0.5 and 10 wt. % of methacrylic acid.   
     
     
       2. The laminated device of claim 1, wherein the adhesive copolymer composition further comprises a vehicle. 
     
     
       3. The laminated device of claim 2, wherein the vehicle is selected from the group consisting of propylene glycol monolaurate and propylene glycol. 
     
     
       4. The laminated device of claim 1, wherein the adhesive copolymer composition further comprises between 0.5 and 10 wt. % of acrylic acid. 
     
     
       5. The laminated device of claim 4, wherein the adhesive copolymer composition further comprises a vehicle. 
     
     
       6. The laminated device of claim 5, wherein the vehicle is selected from the group consisting of propylene glycol monolaurate and propylene glycol. 
     
     
       7. A laminated device for transdermal delivery of molsidomine comprising a backing layer and a matrix layer, the matrix layer comprising: molsidomine; and   an adhesive copolymer composition comprising between 60 and 98 wt % of 2-ethylhexyl acrylate, between 0.1 and 5 wt % of 2-hydroxyethyl methacrylate, between 0.5 and 10 wt. % of methacrylic acid, and between 0.5 and 10 wt. % of acrylic acid; or between 60 and 98 wt. % of 2-ethylhexyl acrylate, between 5 and 25 wt % of 2-hydroxyethyl methacrylate, and between 0.5 and 10 wt. % of methacrylic acid.   
     
     
       8. The laminated device of claim 7, wherein the adhesive copolymer composition further comprises a vehicle. 
     
     
       9. The laminated device of claim 8, wherein the vehicle is selected from the group consisting of propylene glycol monolaurate and propylene glycol. 
     
     
       10. A method for making a matrix composition for use in a laminated device for transdermal delivery of molsidomine, comprising: combining molsidomine with an adhesive copolymer composition comprising between 60 and 98 wt. % of 2-ethylhexyl acrylate, between 0.1 and 25 wt. % of 2-hydroxyethyl methacrylate, and between 0.5 and 10 wt. % of methacrylic acid.   
     
     
       11. The method of claim 10, wherein the adhesive copolymer composition further comprises a vehicle. 
     
     
       12. The method of claim 11, wherein the vehicle is selected from the group consisting of propylene glycol monolaurate and propylene glycol. 
     
     
       13. The method of claim 10, wherein the adhesive copolymer composition further comprises between 0.5 and 10 wt. % of acrylic acid. 
     
     
       14. The method of claim 13, wherein the adhesive copolymer composition further comprises a vehicle. 
     
     
       15. The method of claim 14, wherein the vehicle is selected from the group consisting of propylene glycol monolaurate and propylene glycol. 
     
     
       16. A method of administering molsidomine to a subject, comprising contacting the laminated device of claim 1 to the subject's skin. 
     
     
       17. A method of administering molsidomine to a subject, comprising contacting the laminated device of claim 3 to the subject's skin. 
     
     
       18. A method of administering molsidomine to a subject, comprising contacting the laminated device of claim 4 to the subject's skin. 
     
     
       19. A method of administering molsidomine to a subject, comprising contacting the laminated device of claim 6 to the subject's skin. 
     
     
       20. A method of administering molsidomine to a subject, comprising contacting the laminated device of claim 7 to the subject's skin. 
     
     
       21. A method of administering molsidomine to a subject, comprising contacting the laminated device of claim 9 to the subject's skin.